Clinical Trials Flashcards Preview

Oncology + Palliative > Clinical Trials > Flashcards

Flashcards in Clinical Trials Deck (10):
1

Phase 1

Determines toxicity + establish maximum tolerated dose
Dose escalation is performed, starting at 10% of dose that is lethal in 10% of mice (LD10)

2

Phase 1 pt requirements

Any tumour with no conventional therapy available
Pts must be fit + have normal hepatic + renal function

3

Phase 2

Assesses particular anti-tumour activity in range of cancer
Measures response rate
Not necessary but useful to have a control arm + random allocation for treatment

4

Phase 3

Randomised trials comparing new + established treatments
Assesses overall survival + progression free survival

5

What are response end points?

Tumour growth/ shrinkage
Survival
Toxicity
Quality of life

6

What is RECIST?

Response Evaluation Criteria in Solid Tumours
complete or partial response, progression or stable disease

7

What statistical issues are involved with clinical trials?

Randomisation - reduces bias. Can be blinded or double blinded
Number of patients - to demonstrate a small effect at high significance, large cohort needed
Survival curves - data is presented graphically as a Kaplan Meier curve

8

What is a basket trial?

Tumours harbouring genetic mutations are tested with new drug that targets mutation

9

What is an umbrella trial?

Patients with particular type of cancer are tested to establish genetics of tumours + then offered different experimental treatments based on results

10

What is a platform trial?

Multiple experimental arms are compared with single control arm to reduce costs